BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERA 5.5/6.0 MAS DRIVER

    MDR report key: 8764772 · Received July 5, 2019

    Report

    Report Number
    1723170-2019-03956
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 10, 2019
    Report Date
    November 20, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER 9735023 SOLERA 5.5/6.0 MAS (LOT# 171102) WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND THAT THE TIP OF THE RETURNED DRIVER HAD BEEN BROKEN OFF. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. THE INSTRUMENT WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND DELAYED THE SURGERY BY LESS THAN ONE HOUR. IT WAS REPORTED THAT THE PATIENT HAD PRIOR HARDWARE IN FROM L1-S1 AND NEEDED TO BE DECOMPRESSED AND SAGITTALLY REALIGNED. DURING THE SURGERY, THE SOLERA DRIVER BROKE WHILE TRYING TO PLACE A SCREW IN VERY SCLEROTIC BONE. THE SITE WAS ABLE TO REMOVE THE DRIVER AND THE BROKEN PIECE FROM THE WOUND, FIND ANOTHER NAVIGATED DRIVER, AND PROPERLY PLACE THE SCREW WITHOUT HARM TO PATIENT. NO BROKEN PIECES REMAINED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE SOLERA SCREW DRIVER WAS USED TO GET THE OLD SCREWS OUT BUT THE BONE WAS SCLEROTIC AND THE DRIVER BROKE. THE BROKEN PIECE WAS RETRIEVED SUCCESSFULLY FROM THE WOUND AND NOTHING REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556767 SOLERA 5.5/6.0 MAS DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9735023 171102

    Patients

    Seq Age Sex Outcome Treatment
    1